Surgical biopsy system with remote control for selecting an operational mode

ABSTRACT

A surgical biopsy system is provided for removing at least one tissue sample from a surgical patient. The surgical biopsy system comprises an elongated, hollow piercer and a cutter rotatably and axially positionable relative to the piercer. The piercer has a lateral port for receiving the tissue sample into the piercer. The surgical biopsy system further comprises a power transmission source operatively connected to the cutter for rotating and translating the cutter, a control unit, and a display mounted in a display frame for showing an operator a plurality of operational modes of the surgical biopsy system. The surgical biopsy system further comprises at least one control button operatively connected to the control unit by a circuit and remotely located from the control unit. The operator may actuate the control button(s) to select any one of the operational modes and the selected operational mode is visually identifiable on the display.

This application is a continuation of U.S. patent application Ser. No.13/040,788, filed on Mar. 4, 2011; which is a continuation of U.S.patent application Ser. No. 10/842,314, filed on May 7, 2004, now U.S.Pat. No. 7,914,464, issued Mar. 29, 2011; which is a divisional of U.S.patent application Ser. No. 10/174,032, filed on Jun. 18, 2002, now U.S.Pat. No. 6,752,768, issued Jun. 22, 2004; which is a continuation ofU.S. patent application Ser. No. 09/466,491, filed Dec. 17, 1999, nowU.S. Pat. No. 6,428,487, issued Aug. 6, 2002, all of which areincorporated by reference herein.

Subject matter in this application is related to subject matter in thefollowing co-pending U.S. patent applications: Ser. No. 09/178,075,filed on Oct. 23, 1998, now abandoned; Ser. No. 09/282,142, filed onMar. 31, 1999, now U.S. Pat. No. 6,086,544, issued Jul. 11, 2000; Ser.No. 09/282,140, filed on Mar. 31, 1999, now U.S. Pat. No. 6,120,462,issued Sep. 19, 2000; and Ser. No. 09/365,619, filed on Aug. 2, 1999,now U.S. Pat. No. 6,162,187, issued Dec. 19, 2000. Subject matter inthis application is further related to subject matter in U.S. patentapplication Ser. No. 09/466,391, filed on Dec. 17, 1999, now U.S. Pat.No. 6,432,065, issued Aug. 13, 2002, which is hereby incorporated byreference.

FIELD OF THE INVENTION

The present invention relates, in general, to remotely controlledsurgical instruments, and more particularly, to a remotely controlled,surgical biopsy instrument including an apparatus for remotely selectinga particular mode of operation.

BACKGROUND OF THE INVENTION

The diagnosis and treatment of patients with cancerous tumors,pre-malignant conditions, and other disorders has long been an area ofintense investigation. Non-invasive methods for examining tissueinclude: palpation, X-ray imaging, magnetic resonance imaging (MRI),computed tomography (CT), and ultrasound imaging. When a physiciansuspects that tissue may contain cancerous cells, a biopsy may be doneusing either an open procedure or a percutaneous procedure. For an openprocedure, a scalpel is used to create a large incision to providedirect visualization of and access to the tissue mass of interest. Theentire mass (excisional biopsy) or a part of the mass (incisionalbiopsy) may then be removed. In percutaneous biopsy procedures, aneedle-shaped instrument is inserted through a small incision to accessthe tissue mass of interest and obtain a tissue sample for laterexamination and analysis.

Aspiration and core sampling are two percutaneous methods for obtainingtissue from within the body. In an aspiration procedure, tissue isfragmented into pieces and drawn through a fine needle in a fluidmedium. The aspiration method is less intrusive than most other samplingtechniques, however, it has limited application since the structure oftissue excised by aspiration is destroyed, leaving only individual cellsfor analysis. In core biopsy, a core or fragment of tissue is obtainedin a manner which preserves both the individual cell and the tissuestructure for histological examination. The type of biopsy used dependson various factors, no single procedure is ideal for all cases.

Ethicon Endo-Surgery, Inc., Cincinnati, Ohio currently markets a coresampling biopsy instrument under the MAMMOTOME trademark. The MAMMOTOMEbiopsy instrument is normally mounted on a movable mechanical armattached to an X-ray stereotactic imaging device. The MAMMOTOME biopsyinstrument is adapted to obtain multiple tissue samples from a patientwith only one percutaneous insertion of a piercing element or piercerinto the patient's breast. An operator uses the MAMMOTOME biopsyinstrument to “actively” capture (using a vacuum) tissue prior tosevering it from surrounding tissue. Tissue is drawn into a lateral portat the distal end of the piercer by a remotely actuated vacuum system.Once the tissue is in the lateral port, a cutter is rotated and advancedthrough a lumen of the piercer past the lateral port. As the cutteradvances past the lateral port opening, it severs the tissue in the portfrom the surrounding tissue. When the cutter retracts it pulls thetissue with it and deposits the tissue sample outside of the patient'sbody. The cutter is rotated using a motor, but the operator manuallyadvances and retracts the cutter manually by moving a knob mounted onthe outside of the instrument. The operator has tactile and audiblefeedback to determine whether the cutter is effectively cutting tissue.An alternative instrument wherein the cutter is advanced and retractedmanually is illustrated and described in U.S. patent applications Ser.Nos. 09/282,142 and 09/282,140.

Related patent applications, Ser. Nos. 09/282,142 and 09/282,140 alsodescribe a control method and apparatus for an automatic, core samplingbiopsy device. In one embodiment, cutter translation and rotation aredriven by motors separate from the handpiece and operatively connectedby a control cord and a pair of flexible, rotatable shafts. The operatorsteers the piercer of the handpiece towards a suspect tissue massvisualized using, for example, a handheld ultrasound-imaging device.Buttons on the handpiece generally enable the operator to advance orretract the cutter to obtain a tissue sample, or to activate the vacuumto draw in tissue.

A common problem encountered by operators when using some types ofautomatic, powered surgical devices is the need for the operator to moveback and forth between the patient and a control unit physicallyseparated from the patient. Reaching out to change a setting or modecould require that the operator move from a sterile, surgical field to anon-sterile area, and back again. In a surgical instrument which has aplurality of operational modes, the operator selects a particular modeand the associated control unit automatically operates the devicethrough selected portions of the surgical procedure. For breast biopsyprocedures using handheld biopsy devices such those described above, theoperator may also need to use both hands during the procedure, one tohold the instrument and one to for example, palpate tissue or to use ahandheld ultrasonic imaging device to locate a possible lesion As anexample, either immediately before or after the piercer is inserted intothe suspected tissue, the operator enables a mode of operation which maybe referred to as a Sampling Mode of operation wherein the cutter isautomatically advanced to collect a tissue sample. It is highlyundesirable at this point for the operator to free one hand and to reachover to the control unit to actuate a control in order to select andenable the Sampling Mode of operation. Since a surgical biopsy devicemay have a plurality of operational modes, it is desirable to be able to“scroll” among possible operational mode choices, make a selection, andenable the selected mode, without releasing the handpiece or leaving thesurgical field. The operational mode choices, or “menu”, may be viewed,for example, on a display provided with the surgical biopsy device,

Numerous types of surgical biopsy systems having various types ofcontrol devices are known in the art, U.S. Pat. No. 5,769,086 disclosesan automatic control system for a vacuum-assisted automatic core biopsydevice. The system in U.S. Pat. No. 5,769,086 may be used with animaging device having a monitor for viewing still images of tissue. Ahand-operated cursor (mouse) is used to click on portions of the tissueimage viewed on the monitor to automatically direct a needle of thebiopsy device to the tissue, U.S. Pat. No. 5,830,219 discloses a rotarycutting surgical instrument mounted on the needle guiding stage of astereotactic mammography biopsy system. The system in U.S. Pat. No.5,830,219 is provided with a controlling means having motor controls.Neither Ritchart nor Bird, however, disclose a control adapted forremotely selecting and/or enabling an operational mode from a menu shownon a display without leaving the surgical field.

It would, therefore, be advantageous to design a surgical biopsy systemhaving at least one remotely located (from the control unit) controlbutton for selecting and enabling an operational mode. It would furtherbe advantageous to design a surgical biopsy system wherein an operator,without leaving the surgical field, may actuate the remotely locatedcontrol button(s) while performing the biopsy procedure. It wouldfurther he advantageous to design a surgical biopsy system having adisplay for showing the operator the available operational modes, sothat the operator may scroll through the operational modes using theremotely located control button(s), and enable a selected operationalmode by actuating one or more of the remotely located control buttons.

SUMMARY OF THE INVENTION

The present invention is directed to a surgical biopsy system forremoving at least one tissue sample from a surgical patient. Thesurgical biopsy system comprises an elongated, hollow piercer and acutter rotatably and axially positionable relative to the piercer. Thepiercer has a lateral port for receiving the tissue sample. The surgicalbiopsy system further comprises a power transmission source operativelyconnected to the cutter for rotating and translating the cutter. Thesurgical biopsy system further comprises a control unit and a displaymounted in a display frame for showing an operator a plurality ofoperational modes of the surgical biopsy system. The surgical biopsysystem further comprises at least one control button operationallyconnected to the control unit by a circuit and remotely located from thecontrol unit. The operator actuates the control button to select any oneof the operational modes, whereupon the selected operational modebecomes visually identifiable on the display. The operator may alsoactuate the control button to enable the selected operational mode ofthe surgical biopsy system.

In one embodiment of the present invention, the surgical biopsy systemalso has a handpiece comprising a holster operationally connected to thecontrol unit, and a probe assembly detachably connected to the holster.The piercer extends distally from the probe assembly. The control buttonis operationally mounted on the handpiece so that the operator canselect and enable an operational mode without releasing the handpiece.

In another embodiment of the present invention, the surgical biopsysystem has a remote control device operatively connected to and remotelylocated from the control unit. At least one control button isoperationally mounted on the remote control device. The operatoractuates the control button to select an operational mode of thesurgical system. The control button is used to enable the selectedoperational mode. The remote control device operatively connects to thecontrol unit by a remote control cord. In a further embodiment, thecontrol button on the remote control device is a foot operable controlswitch.

In another embodiment of the present invention, a fluid collectionsystem is provided to assist in drawing tissue into the port,transferring the tissue sample from the patient, removing fluid from thepatient, and injecting fluid into the patient. In addition, translationin the distal direction of the cutter is manually controllable by aforward button, translation in the proximal direction of the cutter ismanually controllable by a reverse button, and actuation of the fluidcollection system is manually controllable by a vacuum button. At leastone of the forward, reverse, and vacuum buttons is used to select andenable an operational mode from a plurality of operational modes shownon a display.

BRIEF DESCRIPTION OF THE DRAWINGS

The novel features of the invention are set forth with particularity inthe appended claims. The invention itself, however, both as toorganization and methods of operation, together with further objects andadvantages thereof, may best be understood by reference to the followingdescription, taken in conjunction with the accompanying drawings inwhich:

FIG. 1 is an isometric view of a surgical biopsy system for thecollection of at least one core tissue sample from a surgical patient;

FIG. 2 is an isometric view of a probe assembly of the surgical biopsysystem of FIG. 1 with the left handle shell removed;

FIG. 3 is an isometric view of the surgical biopsy system of FIG. 1,showing a display pivotally and tiltably mounted on a control console;

FIG. 4 is a schematic diagram representation of a control unitinterfaced with the surgical biopsy system of FIG. 1;

FIG. 5 is a schematic diagram of a first electronic circuit includingcontrol buttons for use with the surgical biopsy system of FIG. 1,interfacing with a portion of the control unit of FIG. 4;

FIG. 6 is a schematic diagram of a second electronic circuit includingfoot operated control switches interfacing with a portion of the controlunit of FIG. 4;

FIG. 7 is an illustration of one screen image on the display of thecontrol unit shown in FIG. 3 wherein a number of operational modes arerepresented by icons;

FIG. 8 is a schematic diagram wherein each block is representative ofone operational mode or method of implementing a particular operationalmode;

FIGS. 9A and 9B include flowcharts illustrating the steps in oneembodiment of a particular mode of operation;

FIGS. 10A, 10B, 10C, 10D, and 10E include flowcharts illustrating thesteps in one embodiment of a further mode of operation;

FIGS. 11A and 11B include flowcharts illustrating the steps in oneembodiment of a further mode of operation;

FIG. 12 is a flowchart illustrating the steps of a “smart vac” routine;and

FIG. 13 is a flowchart illustrating the steps of a “vacuum/scroll”routine.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 shows a surgical biopsy system 10 comprising a handpiece 40, afluid collection system 22, a control unit 300, a power transmissionsource 24, a video monitor 28 and a remote control 16. Detaileddescriptions of surgical biopsy system 10 are contained in U.S. patentSer. No. 09/282,140 filed Mar. 31, 1999, which is hereby incorporatedherein by reference. Handpiece 40 comprises a holster 44 operatively andremoveably attached to a probe assembly 42. Handpiece 40 is lightweight,ergonomically shaped, and hand manipulatable. Probe assembly 42 includesan elongated piercer 70 having a piercer tip 72 for penetrating softtissue of a surgical patient. Piercer 70 comprises a piercer tube 74 anda vacuum chamber tube 76. Vacuum chamber tube 76 of piercer 70 may befluidly connected, automatically or manually, to fluid collection system22 by a lateral vacuum line 30. Similarly, axial vacuum line 32 may befluidly connected, automatically or manually, to fluid collection system22. Lateral and axial vacuum lines, 30 and 32, are detachably connectedto fluid collection system 22. Holster 44 is operatively connected tocontrol unit 300 by a control cord 38 and to power transmission source24 by a translation shaft 34, and a rotation shaft 36. Shafts 34 and 36are preferably flexible so that the operator may easily manipulatehandpiece 40 with one hand,

Still referring to FIG. 1, holster 44 further comprises: a forwardbutton 46 which may be used to move cutter 96 distally through piercertube 74 and sever tissue collected in port 78; a reverse button 48 whichmay be used to move cutter 96 proximally through piercer tube 74 andthereby moving the tissue sample in port 78 to a collection surface 41;and a vacuum button 50 which may be used to open or close vacuum lines30 and 32, thereby generally for administering and/or removing fluidsfrom handpiece 40.

An operator may use surgical biopsy system 10 with a handheld,ultrasonic imaging device for visualizing the removal of suspectedtissue from a patient. The imaging device provides a real-time image oflesions, microcalcifications, and high-density masses within the breasttissue of the patient. The operator may view a suspected tissue masswhile guiding piercer tip 72 of handpiece 40 to a location adjacent tothe suspected tissue in order to obtain a core tissue sample. Thesurgical biopsy system 10 may also be mounted in a holder of amechanical arm or the like, and used with other imaging devices such asstereotactic X-ray.

FIG. 2 is an isometric view of probe assembly 42 with a left handleshell removed to reveal a cutter 96 which has a cutter blade 97. Cutter96 is an elongated, metal tube that translates in either directionbetween a fully retracted position (where cutter blade 97 is immediatelyproximal to collection surface 41) and a fully deployed position (wherecutter blade 97 is immediately distal to port 78). During portions ofcutter translation, cutter 96 is rotated at an appropriate speed forsevering tissue from a patient. Cutter 96 is attached to a carriage 92,which is driven by a lead screw 90, which in turn is driven bytranslation shaft 34 (FIG. 1). For the embodiment shown in FIG. 2, onerevolution of lead screw 90 causes cutter 96 to translate 0.100 inches.There are key intermediate positions along the translation length ofcutter 96. When cutter blade 97 of cutter 96 reaches each of thesepositions, and depending upon the operational mode the system is in,important adjustments to either the cutter rotational speed (sometimescalled rotation speed) or the cutter translational speed (sometimescalled translation speed), or both, are made automatically. Fluidcollection system 22 may also be engaged according to the position ofcutter 96, which includes cutter blade 97, position and depending onoperational mode being used. For the embodiment of surgical biopsysystem 10 described herein, there are four positions along the length ofthe cutter translation. At these positions, signals are sent to controlunit 300 and used to make appropriate adjustments to cutter rotationalspeed and/or cutter translational speed. As shown in FIG. 2, the fourcutter positions are the following; a first position, Position 1, wherecutter blade 97 is immediately proximal to tissue sampling area 41; asecond position, Position 2, where cutter blade 97 is immediately distalto tissue sampling area 41; a third position, Position 3, where cutterblade 97 is immediately proximal to port 78; and a fourth position,Position 4, where cutter blade 97 is immediately distal to port 78. Thefour cutter positions are given by way of example although numerousother cutter positions may be used in the present invention forautomatically signaling adjustments to cutter rotational speed and/ortranslational speed, and for engaging fluid collection system 22. Forexample, a fifth position of cutter 96 may be at a location about 2 mmproximal to port 78. The rotation,of the cutter 96 may then beaccelerated to the appropriate speed (1100 rpm, for example) slightlybefore cutter 96 encounters tissue prolapsed into port 78. Likewise, asixth position of cutter 96 may be at a location about 2 mm distal toport 78 so that cutter 96 is decelerated after it has traversed theentire length of the port 78.

FIG. 3 shows surgical biopsy system 10 having a remote control 16 (alsocalled a remote control device) operatively connected to a console 302(containing control unit 300) by a remote control cord 13. Console 302of FIG. 3 is shown to be mounted on a portable, wheeled unit having astorage space 303 that may be used, for example, for storing surgicalsupplies and equipment. Remote control 16 comprises a first remoteswitch 17, a second remote switch 18, and a third remote switch 19.Remote switches 17, 18 and 19 perform the same functions as buttons 46,48, and 50 on handpiece 40 (FIG. 1). Remote control 16, as shown in theembodiment of FIG. 3, may be foot operable. A suitable example of a footoperable, remote control 16 is TREADLITE, a footswitch sold under thetrademark and available from Linemaster, Inc, and part number T-91-SWNO.Those skilled in the art will appreciate that remote control 16 may haveother embodiments, including those adapted for hand operation or othermeans of actuation. Wireless means of interfacing with control unit 300are also available and could be incorporated into the present invention,

FIG. 3 also shows video monitor 28 operatively connected to console 302(containing control unit 300) by a video cord 29. A video outputconnection (not shown) is provided on the back of console 302 andoperatively connected to control unit 300. Video monitor 28 displays theimage shown on a display 334 mounted on console 302, and enables theoperator, assistant, patient, or others to view the display image moreeasily. Video monitor 28, in addition to facilitating the surgicalprocedure, may be used as a teaching tool for other users. The videoimage supplied from control unit 300 may also be transmitted withoutwires to other locations, or may be recorded on conventional videorecording devices for later viewing. In the embodiment shown in FIG. 3,a display frame 337 supports display 334 and is tiltably attached to aturntable 338. Turntable 338 is rotatably attached to the top of console302. Display 334 is not restricted to the location shown in FIG. 3. Forexample, a smaller version of display 334 may be mounted on handpiece 40or removeably attached to the surgical table on which the patient islying.

FIG. 4 is a representation of surgical biopsy system 10 of FIG. 1illustrating the interface of the electro-mechanical components tocontrol unit 300. In the embodiment of the surgical biopsy system 10shown in FIG. 3, all of the components of FIG. 4 are contained inportable console 302. The operator may therefore move surgical biopsysystem 10 easily from one room to another, such as in a physician'soffice or clinic. For each new patient, a new sterile probe assembly 42may be operatively connected to reusable holster 44. Handpiece 40 (probeassembly 42 and holster 44 together) may be mounted, for example, to anX-ray, stereotactic table already in the room, or handheld and used incombination with a handheld ultrasonic imaging device.

FIG. 4 illustrates the connection of handpiece 40 and power transmissionsource 24 to control unit 300. Power transmission source 24 comprises arotation motor and a translation motor (not shown). A rotation sensor 54is shown mounted in handpiece 40 and operatively connected toswitchboard 52 by a conductor 57. Rotation sensor 54 counts therevolutions of lead screw 90 (see FIG. 2), providing a signal to controlunit 300 and representing the actual position of cutter 96 as ittranslates between positions 1 and 4. It is therefore possible forcontrol unit 300 to compare the actual axial position of cutter 96 tothe position commanded by control unit 300. In one embodiment, rotationsensor 54 provides a signal of 1200 “counts” per revolution to controlunit 300. During the translation of cutter 96, control unit 300 sums thetotal number of counts received from rotation sensor 54. Due tomechanical losses (shaft twisting, etc.) the total number of counts forrotation sensor 54 is typically less than the total number of countscommanded by control unit 300. When the difference of the actual andcommanded positions is significant enough to represent a substantialcutter axial position error, the operator is alerted and may halt theprocedure. A cutter translation position differential, PD, represents amaximal, allowable differential between the summed counts of therotation sensor 54 in handpiece 40 and the commanded position in termsof counts. In one embodiment of the present invention, control unit 300is programmed to alert the operator when PD is more than 1000 counts,corresponding to a translation position error of 0.083 inches (1000/1200of one revolution of lead screw 90, or 0.83 times 0.100 inches).

Control unit 300 of FIG. 4 provides a means for either increasing cutterrotation speed or slowing cutter translation speed, or both, if cutter96 rotation speed slows below a predetermined limit due to obstructionsto cutter 96 or mechanical resistance within the system. Control unit300 also provides a means for varying cutter translation and rotationspeed in response to cutter axial position.

In FIG. 4 control unit 300 is shown to include elements such as, adisplay 334, a backlight driver 335, and a touchscreen 336. At the heartof control unit 300 is a microprocessor 408, which is designed toperform logic operations that may be translated into simpleelectromechanical actions. Display 334 prompts and informs the operatorduring the operation of surgical biopsy system 10. Touchscreen 336covers display 334 for one user interface. Touchscreen 336 iselectronically connected to a touchscreen controller 402 in control unit300. A backlight (not shown) is integrally constructed within display334 and provides illumination of display 334 when control unit 300 ispowered-up. A backlight driver 335 interfaces the backlight withmicroprocessor 408. A suitable example of backlight driver 335 is PartNumber LS520 available from Xentek, Inc.

Still referring to FIG. 4, touchscreen controller 402 allows controlunit 300 to respond to the operator's touch. A LCD controller 404 isprovided to interface between microprocessor 408 and display 334. LCDcontroller 404 reduces the burden of microprocessor 408 by efficientlycontrolling display parameters such as color, shading, screen updaterates, and provides temporary storage for display information. Aminiature annunciator 332 is provided with control unit 300 in order toprovide the operator with audible feedback “beeps” upon each activationof an icon control on display 334. Annunciator 332 interfaces withmicroprocessor 408 by an oscillator 400 which converts the digitalsignal from microprocessor 408 to analog, periodic output signals, thuscontrolling the audio frequency of annunciator 332.

Still referring to FIG. 4, a first and a second controller and driver,390 and 406, convert digital signals from microprocessor 408 into analogmotor signals for controlling power transmission source 24 rotationaldirection and speed. Closed loop, digital, translation speed control ofpower transmission source 24 is also achieved within controller anddriver 390 using feedback signals from rotation sensor 54 in handpiece40. Handpiece 40 contains a switchboard 52 having a first circuit 212(see FIG. 5). A serial controller 380 is electronically connected toswitchboard 52 by control cord 38. Serial controller 380 coordinatesinformation exchange across the serial communication link betweenswitchboard 52 and microprocessor 408. An optional card reader 382 maybe provided in control unit 300 for reading data from a memory card inorder to facilitate future software upgrades and servicing. A serialport 384 is provided for the bi-directional data exchange in a serialtransmission mode, again to facilitate future software upgrades andservicing. A first PWM (pulse width modulation) driver 386 interfaces afirst solenoid 23 with microprocessor 408. First PWM driver 386 convertsa digital input signal from microprocessor 408 to an analog outputsignal having a wave of fixed frequency and amplitude, but varying dutycycle. First PWM driver 386 outputs a 100% duty cycle frequency to moveinitially a first solenoid 23 in order to open lateral vacuum line 30 tothe vacuum source of fluid collection system 22. Once first solenoid 23is actuated, the duty cycle is reduced to a level that maintainssolenoid position, thus minimizing power requirements. A second PWMdriver 388 similarly interfaces a second solenoid 25 with microprocessor408 to open axial vacuum line 32 to the vacuum source. A third PWMdriver 394 interfaces with a pressure sensor (not shown) of fluidcollection system 22 and with an A/D converter 396.

Still referring to FIG. 4, a RAM (Random Access Memory) memory device392 is provided with microprocessor 408 for storing variable data, andinherently loses stored data when power is removed. A flash memorydevice 398 is provided with microprocessor 408 to store data, includingthe main application program or variable data, even without power. A/Dconverter 396 converts voltage signals corresponding to vacuum pressuresignals from fluid collection system 22 into digital signals which aretransmitted to microprocessor 408, and used by microprocessor 408 tomaintain a desired vacuum pressure in fluid collection system 22.Control unit 300 is provided with a conventional, 48-volt DC powersupply (not shown) used in combination with standard DC-to-DC convertersand electrical voltage regulators in order to supply reduced voltages tothe components of control unit 300.

FIG. 5 is a schematic representation of first circuit 212 of switchboard52 (see FIG. 4) interfacing with rotation sensor 54 of handpiece 40,serial controller 380 of control unit 300, and controller and driver 390of control unit 300.

Rotation sensor 54 may be implemented using, for example, an encoder tocount the shaft resolutions. First circuit 212 comprises amicrocontroller 201 operatively connected in parallel to forward button46, reverse button 48, and vacuum button 50. Rotation sensor 54interfaces with microcontroller 201 and microprocessor 408 via a firstcomparator 208 and a second comparator 209. Comparators 208 and 209convert sine wave peak-to-peak waveforms (from rotation sensor 54) tosquare wave logic level outputs, and are available as P/N LM2903 fromNational Semiconductor Corporation. A serial EEPROM 207 is provided tostore permanent non-volatile data for reliability and is available asP/N 25C040-SN from Microchip, Inc. A serial receiver 206 interfacesserial controller 380 of control unit 300 with microcontroller 201 andprovides serially formatted data for storage in non-volatile memory.Serial receiver 206 is available as P/N IC-RS-485 SN 75 LBC 179D fromTexas Instrument Corp. A differential driver 205 interfaces withmicrocontroller 201, serial controller 380, controller and driver 390,and rotation sensor 54 to communicate serial data and rotation sensor 54signals. Serial receiver 205 is available as P/N IC-RS-485 LTC 486CSfrom Texas Instrument Corp.

FIG. 6 is a schematic representation of a second circuit 214 in remotecontrol 16 interfacing with microprocessor 408 of control unit 300.Second circuit 214 is located inside of remote control 16 and comprisesa first remote switch 17, a second remote switch 18, a third remoteswitch 19, and a fourth remote switch 20 operatively connected tomicroprocessor 408 of control unit 300 (FIG. 4). Remote switches 17, 18and 19 functionally correspond to forward button 46, reverse button 48,and vacuum button 50 of handpiece 40 of FIG. 1. A fourth remote switch20 is provided to expand the number of functions that may be performedby surgical biopsy system 10, but is not utilized in the embodiment ofthe present invention described herein. In this embodiment remoteswitches 17, 18, 19, and 20 are momentary switches that are normallyopen.

Still referring to FIG. 6, a device identifier 26 is provided on secondcircuit 214 and comprises conductors for providing a feedback signal tocontrol unit 300. The control method logic of microprocessor 408proceeds according to the device identifier 26 signal. Device identifier26 tells microprocessor 408 if remote control 16 is physically pluggedin to control unit 300 and, in one embodiment of the present invention,the presence of device identifier 26 renders buttons 46, 48, and 50 ofhandpiece 40 inoperable. Instructions to the operator as indicated ondisplay 334 take into account whether the operator is using handpiece 40or remote control 16 to operate the surgical biopsy system 10, and thegraphics/instructions of display 334 are changed accordingly. When anoperator chooses to use remote control 16 with handpiece buttons 46, 48and 50 inoperable, handpiece 40 may be used without concern forinadvertently pressing buttons 46, 48, and 50 during the procedure andengaging an undesired function.

In one embodiment of the present invention, three separate operationalmodes are available to the operator: a Positioning Mode, a SamplingMode, and a Clear Probe Mode. FIG. 7 shows a screen image 81 of display334 on which a control for each operational mode is displayedgraphically in the form of icons, which icons may be associated withtouchscreen controls. By pressing touch screen 336 in the region of theicon or otherwise selecting an icon as described herein, the iconselected becomes highlighted by a color change or other visualindication accompanied by a distinct audible beep from annunciator 332.

Screen image 81 is one of a plurality of images that appear on display334 during the operation of surgical biopsy system 10. Screen image 81includes a positioning control icon 346, a sampling control icon 348,and a clear probe control icon 350, which are positioned above a messagewindow 354. Screen image 81 also includes a handpiece icon 344 with acutter position indicator 373 to indicate the real-time position ofcutter 96. A lateral vacuum indicator 356, an axial vacuum indicator358, a forward control indicator 360, a reverse control indicator 362,and a vacuum control indicator 364 each become visually highlightedwhenever activated by, for example, depressing a button on handpiece 40or remote control device 16. Screen image 81 also includes an exit icon352. Which may be selected by an operator to exit the screen image 81.In one application, when exit icon 352 is selected, a new options screenis displayed with the following four options: use a new probe assembly,use a new holster, return to the procedure, and change settings. Avolume control icon 368 is provided for setting the volume of theaudible signals from control unit 300.

During a biopsy procedure, each mode of operation represented by icons346, 348 and 350 is used for a particular portion of the general biopsyprocedure. FIG. 8 includes blocks 216, 221 and 224 each of which arerepresentative of a mode of operation which may be initiated byselecting one of icons 346, 348 or 350. Each of the selectable modes ofoperation are described in greater detail with respect to the flowchartsin FIGS. 9-13. The flowcharts illustrated in FIGS. 9-13 will bedescribed with reference to forward button 46, reverse button 48 andvacuum button 50 of handpiece 40, however, it will be apparent to one ofskill in the art that the modes of operation illustrated in FIGS. 9-13will work with functionally corresponding switches of remote control 16.In particular, first remote switch 17, second remote switch 18, andthird remote switch 19 may functionally correspond to forward button 46,reverse button 48 and vacuum button 50.

Referring to FIG. 8, block 216 represents the Positioning Mode: When inthe Positioning Mode, the operator can accomplish preparatory tasks suchas priming or flushing fluid collection system 22, verifying that port78 is oriented adjacent to the tissue mass to be sampled, or injectinganesthetic fluid into tissue through port 78. In the Positioning Mode,the operator may translate cutter 96 axially in either direction.Normally cutter 96 does not rotate when being translated in thePositioning Mode. In the Positioning Mode, depressing forward button 46moves cutter 96 distally until forward button 46 is released or untilPosition 4 is reached. Depressing reverse button 48 moves cutter 96proximally until reverse button 48 is released or until Position 1 isreached. Depressing vacuum button 50 connects port 78 to lateral vacuumline 30 and axial vacuum line 32 until vacuum button 50 is released.With vacuum button 50 depressed, fluid flows from port 78 throughlateral vacuum line 30 and from cutter 96 through axial vacuum line 32to fluid collection system 22.

Upon completion of the preparatory or intervention task in thePositioning Mode, the operator may select the Sampling Mode of operationwhich is represented by block 221 in FIG. 8. When the system is in theSampling Mode of operation, probe assembly 42 is programmed toautomatically obtain tissue samples from the patient using one of twomethods. The method used depends on an election by the operator duringan operator's preference selection procedure that is completed beforethe Sampling Mode is selected. In the Sampling Mode, cutter translationspeed, cutter rotation speed and actuation of fluid collection system 22are preprogrammed and are controlled by feedback signals indicating theposition of cutter blade 97. In the present embodiment, two samplingmethods are available to the operator: Sampling Method A, which isrepresented by block 222 in FIG. 8; and Sampling Method B, which isrepresented by block 223 in FIG. 8. For either method, the operatorpresses and holds forward button 46 as cutter 96 moves from Position 1to Position 2. This deliberate action insures that the operator isintentionally advancing cutter 96 while cutter blade 97 is exposed as itmoves across collection surface 41. If Sampling Method A was selectedduring the preference selection procedure, pressing forward button 46once moves cutter 96 from Position 2 to Position 4 severing a tissuesample in port 78 and stops cutter 96 at Position 4. Then when reversebutton 48 is pressed once, cutter 96 moves from Position 4 to Position 1and the severed tissue sample is deposited onto collection surface 41.If Sampling Method B was selected during the preference selectionprocedure, pressing forward button 46 once, moves cutter 96 fromPosition 2 to Position 4, severing a tissue sample. Cutter 96 thenpauses for a predetermined length of time (e.g. 2-6 seconds), and thenmoves from Position 4 to Position 1, depositing the severed tissuesample onto collection surface 41.

The Clear Probe Mode as represented by Block 224 in FIG. 8, may be usedto automatically clear tissue and/or fluids from piercer tube 74. In oneembodiment of the surgical system, the Clear Probe Mode may includethree clear probe methods, A, B, or C, which are selected by an operatorduring the preference selection procedure prior to entering Clear ProbeMode. Once the system is in the Clear Probe Mode, the operator pressesand holds forward button 46 as cutter 96 advances from Position 1 toPosition 2. In the Clear Probe Method A 225, an operator presses forwardbutton 46 and cutter 96 advances to Position 3, axial vacuum line 32pulses automatically, and cutter 96 returns to Position 1. For ClearProbe Method B as represented by block 226, the operator presses theforward button 46 and cutter 96 automatically moves to Position 4, axialvacuum line 32 pulses (opens and closes repeatedly), and then the cutter96 returns to Position 1. For Clear Probe Method C as represented byblock 227, the operator presses forward button 46 and cutter 96automatically moves to Position 3, axial vacuum line 32 is pulsed,cutter 96 moves to Position 4, axial vacuum line 32 is pulsed again, andcutter 96 returns to Position 1. Upon completion of one of clear probemethods A, B, or C, the operator may select any mode including theSampling Mode which is represented by block 221.

FIGS. 9A and 9B include flowcharts illustrating the steps in oneembodiment of a Positioning Mode of operation. The flowchart in FIGS. 9Aand 9B is divided in two parts at circles containing like letters. Theflowcharts in FIGS. 9A and 9B illustrate one example of the interactionbetween an operator and control unit 300 with the system in the PositionMode of operation. In one embodiment of the present invention, thesystem starts in the Position Mode when screen image 81 comes up and itis not necessary to select position control icon 346. If, however, thesystem is not in the Position Mode, position control icon 346 may beselected by the surgeon using the procedure described herein withreference to FIG. 13. In step 700 of FIG. 9A, when position control icon346 is selected or screen image 81, display 334 displays “POSITIONINGMODE” in message window 354 (step 701), positioning control icon 346 ishighlighted (step 702), forward button 46, reverse button 48, and vacuumbutton 50 are enabled (step 704) and control unit 300 sounds a distinct“beep” (step 705). In step 706 power transmission source 24 is set torespond to the forward button 46 and reverse button 48. In step 707 thevacuum solenoids, 23 and 25, are set to respond to vacuum button 50. Instep 708 display 334 shows the message “1. USE FORWARD OR REVERSEBUTTONS TO MOVE CUTTER. 2. DOUBLE-CLICK VACUUM BUTTON TO ENGAGESCROLLING,” Continuing the flowchart logic in FIG. 9B, in steps 709, 713and 718 control unit 300 queries handpiece 40 to see if forward button46 has been pressed, if the reverse button 48 has been pressed, or ifthe vacuum button 50 has been pressed. If the operator pressed theforward button 46 in step 709 then in step 710 cutter 96 translatesforward until forward button 46 is released. In step 711, thetouchscreen controls, handpiece buttons 46 and 50 or remote controlswitches 17, 18 and 19 are disabled until forward button 46 is released.In step 712 cutter 96 automatically stops at Position 4. If the reversebutton 48 was pressed in step 713 then in step 714 cutter 96 translatesproximally (backwards) until the operator releases reverse button 48 orcutter 96 stops at Position 1 in step 716. In Step 715 the touchscreencontrols, handpiece buttons 46, 48 and 50, and remote control switches17, 18 and 19 are disabled until reverse button 48 is released.

Translation of cutter 96 is measured in step 717: If cutter translationposition differential is less than predetermined value PD then thepositioning control mode continues to step 709. If not, control unit 300sounds a distinct “beep” in step 720 and displays an error message instep 721.

FIGS. 10A, 10B, 10C, 10D, and 10E include a flowchart illustrating thesteps in one embodiment of a Sampling Mode of operation. The flowchartin FIGS. 10A, 10B, 10C, 10D and 10E is divided into five parts atcircles containing like letters. The flowcharts in FIGS. 10A, 10B, 10C,10D and 10E illustrate one example of the interaction between theoperator and control unit 300 with the system in the Sampling Mode ofoperation. As illustrated in step 600 of FIG. 10A, when sampling controlicon 348 is selected on screen image 81 the Sampling Control Mode ofoperation is initiated. In step 601 handpiece buttons 46, 48 and 50 andremote control switches 17, 18 and 19 are disabled. In step 602 samplingcontrol icon 348 on screen image 81 is highlighted. In step 603 display334 shows “SAMPLING MODE” in message window 354, and in step 604 controlunit 300 sounds a distinct “beep”. Next, in step 605, cutter 96translates to Position 1. Translation of cutter 96 is monitored in step606 and, if position differential is not within PD, control unit 300sounds a “beep” and displays an error message in step 607. In step 608touchscreen controls, handpiece buttons 46, 48 and 50, and remotecontrol switches 17, 18 and 19 are enabled. Otherwise, Sampling ControlMode continues. In step 609 forward button 46 and vacuum button 50 areenabled, touchscreen controls are also enabled in step 610, and in step611 display 334 shows “1. USE FORWARD BUTTON TO TAKE SAMPLE, 2. USE ANYBUTTON TO ABORT. 3. DOUBLE-CLICK VACUUM BUTTON TO ENGAGE SCROLLING.”

When the operator presses the forward button with the system in theSampling Mode, it is detected in step 612. In step 613, the operator hasthe option of double-clicking the vacuum button to enter a vacuum/scrollroutine (to be described with reference to FIG. 13) in order to select adifferent operational mode, such as Positioning Mode or Clear ProbeMode. If the operator selects the forward button, the system stays inthe Sampling Mode and in step 615 touchscreen controls are disabled, instep 616 a “beep” is sounded, and in step 617 the “smart vac” routine(to be described with reference to FIG. 12) is ended if it had beenpreviously engaged. In step 618, the operator presses and holds forwardbutton 46 until cutter 96 reaches Position 2. In step 619, if the buttonis released early a message “PRESS AND HOLD FORWARD BUTTON” is displayedto remind the operator to hold forward button 46 down until Position 2is reached. In step 620, cutter 96 continues to translate to Position 4.In step 621 lateral vacuum line 30 and axial vacuum line 32 are openedautomatically to connect fluid canister 318 to handpiece 40. Asillustrated in step 622, forward button 46, reverse button 48, andvacuum button 50 are enabled to abort (stop cutter translation androtation) the Sampling Mode by pressing any one of them once. In step623, cutter rotation speed is accelerated to Q before reaching Position3. A preferred value of Q is 1100 revolutions per minute, although thisvalue may vary depending upon the requirements of the system.

In step 624 of FIG. 10C, cutter translation position is again comparedto PD. If the actual cutter position differential is not within PD,control unit 300 sounds a “beep” and displays an error message in step625 and the controls and buttons are enabled in step 626. If cutter 96is translating properly and is proximal to Position 4, cutter 96continues to translate distally unless any button on handpiece 40 or onremote control 16 is pressed to abort the sampling mode step 628. Oncecutter 96 reaches Position 4, the Sampling Mode proceeds in accordancewith the flowchart illustrated in FIG. 10D. If the Sampling Mode isaborted at step 628, cutter translation and rotation is stopped in Step629, and both lateral and axial vacuum lines, 30 and 32, are closed instep 630. Display 334 then reads “SAMPLE CYCLE INTERRUPTED. USE FORWARDBUTTON TO CONTINUE. USE REVERSE BUTTON TO RETRACT.” in step 631.

In FIG. 10D the system is in the Sampling Mode and cutter 96 istranslating towards Position 4 at a predetermined translation speed. Instep 632 the Sampling Mode continues according to which of the twosampling mode methods, A or B, was pre-selected by the operator duringthe preference selection routine. If Sampling Method B was selected,then cutter rotation is stopped at Position 4 step 633, lateral vacuumline 30 is closed step 634, and cutter 96 dwells at Position 4 for Xseconds 635. A preferred value for X is approximately in the range of 2to 6 seconds. Cutter 96 then automatically translates back to Position1. If Sampling Method A was pre-selected by the operator, cutterrotation is stopped at Position 4 in step 636 and lateral vacuum line 30is closed in step 637. The reverse button 48 is enabled in step 638 anddisplay 334 reads “USE REVERSE BUTTON TO RETRIEVE SAMPLE.” in step 639.When the reverse button is pressed in step 659, the buttons on handpiece40 and on remote control 16 are disabled. Cutter translation Position 1begins in step 640. Cutter translation position is checked in step 641.If cutter translation position is not within PD in step 642, controlunit 300 sounds a “beep” and an error message is displayed in step 607.If cutter translation position is OK, then cutter 96 translates toPosition 1. When cutter 96 reaches Position 1, touchscreen controls 643are enabled in step 643, forward button 46 and vacuum button 48 areenabled in step 644, axial vacuum 32 is closed in step 645, and thesmart vac routine of FIG. 12 is begun if pre-selected during thepreference selection routine in step 646.

In FIG. 10E the Sampling Mode flowchart continues. In step 654 screenimage 81 displays: “1. REMOVE SAMPLE, 2. USE FORWARD BUTTON FOR NEXTSAMPLE. 3. IF NO SAMPLE, SCROLL AND SELECT CLEAR PROBE (DOUBLE-CLICKVACUUM BUTTON TO ENGAGE SCROLLING.)” The Sampling Mode flowchart resumesat step 612 of FIG. 10B, where control unit 300 queries handpiece 40 tosee if the forward button 48 is depressed. If the Sampling Mode wasaborted as described in steps 628-631 of FIG. 10C, then the samplingmode logic proceeds to step 647 in FIG. 10E. In step 647 control unit300 determines which button was pushed after the Sampling Mode wasaborted. If reverse button 48 was pressed, then in step 648 all buttonson handpiece 40 are disabled axial vacuum line 32 is opened in step 649,and cutter 96 is retracted to Position 1 in step 650. In step 655 theSampling Mode moves back to step 606 of FIG. 10A to check positionaldifference. If in step 647 vacuum button 50 is pressed, then in step 651both lateral vacuum line 30 and axial vacuum line 32 are opened andcontrol unit 300 ignores a double-click. If in steps 647 forward button46 was pressed, then in step 652, cutter rotation is increased to speedQ and lateral and axial vacuum lines are opened again in step 653.Cutter 96 then translates to Position 4 in step 656. In step 657, cuttertranslation position is checked again as described for step 624 of FIG.10C.

FIGS. 11A and 11B include a flowchart illustrating the steps in oneembodiment of a Clear Probe Mode of operation. The flowchart in FIGS.11A and 11B is divided in two parts at circles containing like letters.The flowcharts in FIGS. 11A and 11B illustrate the Clear Probe Mode ofoperation. As illustrated in step 801 of FIG. 11A, when clear probecontrol icon 350 is selected, the Clear Probe Mode of operation isinitiated and display 334 displays “CLEAR PROBE MODE” in message window354. In step 802, forward button 46 and vacuum button 50 are enabled, instep 802 the Clear Probe Mode is highlighted and control unit 300 soundsa distinct “beep” in step 804. In step 805, control unit 300 displays“1. USE FORWARD BUTTON TO CLEAR PROBE. 2. DOUBLE-CLICK VACUUM BUTTON TOENGAGE SCROLLING.” If the operator presses and holds vacuum button 50 instep 806, lateral vacuum line 30 is opened until vacuum button 50 isreleased. If the operator double-clicks on vacuum button 50, then thevacuum/scroll routine of FIG. 13 begins. If the operator presses forwardbutton 46, then all controls and buttons are disabled in step 807. IfClear Probe Method A had been pre-selected, in step 808 cutter 96translates to Position 4. If the Clear Probe Methods B or C had beenselected, cutter 96 translates to Position 3 in step 809.

The flowchart illustrating the Clear Probe Mode of operation continuesin FIG. 11B at step 810 where cutter translation position is againchecked. If the cutter translation position differential is not withinPD as before, then a “beep” is sounded in step 811, an error message isdisplayed in step 812 and the controls are enabled in step 813. If thedifferential is within PD, then, in step 814, the axial vacuum line 32is “pulsed” by opening it to fluid collection system 22 for 0.5 seconds,closing it for 0.5 seconds, and repeating the sequence two more times.Next, in step 815, control unit 300 determines whether Clear ProbeMethod C had been pre-selected by the operator. If not, then cutter 96translates to Position 1, per step 816, with the axial vacuum on duringtranslation. If Clear Probe Method C has been selected, then, in step817, cutter 96 translates to Position 4. Then in step 818 cuttertranslation position differential is checked, and, if it is within PD,axial vacuum line 32 is pulsed again in step 819. If the positiondifferential is not within PD, then, in step 821, the flowchart goes tostep 811. After pulsing axial vacuum line 32 in step 819, cutter 96translates to Position 1, with axial vacuum on during translation, instep 816. Again as cutter 96 translates to Position 1, in step 822 thecutter translation position differential is checked to be sure it iswithin PD. If the differential is within PD, all controls and buttonsare enabled and the Clear Probe Mode of operation proceeds to step 805of FIG. 11 A so that the mode may either be repeated or scrolled to analternate mode of operation (positioning or sampling).

FIG. 12 is a flowchart illustrating a smart vac routine for dislodgingtissue that may be stuck in port 78. If the operator pre-selected thesmart vac routine during the operator's preference selection the smartvac routine engages automatically, at Position 1, after a first samplehas been removed, in the Sampling Mode of operation Once control unit300 engages the smart vac routine in step 900, there is a momentarydelay of Y seconds in order to allow time for the operator to remove thetissue sample from collection surface 41 in step 908. A preferred valuefor Y is approximately eight seconds. Once the smart vac routine isinitiated, then lateral vacuum line 30 is opened to the vacuum sourcefor 1.0 seconds, closed for 1.0 seconds, and the process is repeateduntil the next sample is taken (see step 617, FIG. 10B), or until thevacuum button 50 is pressed. If the vacuum button is depressed for along time (at least about 0.5 seconds) then in step 902 the axial andvacuum lines are opened. If vacuum button 50 was depressed and held,then when vacuum button 50 is released the smart vac routine thencontinues to pulse lateral vacuum line 30 in step 901. If vacuum button50 was pressed quickly, then, in step 904, axial vacuum line 32 andlateral vacuum line 30 are closed. In step 905, the steps are repeated,short press of vacuum button 50 sends the smart vac routine to step 901to pulse lateral vacuum line 30. A long press sends the smart vacroutine to step 907 and step 907 opens the axial vacuum line 32 andlateral vacuum line 30 while vacuum button 50 is depressed. Then bothlines are closed at step 904, when the button is released. If at step905 the vacuum button was not pressed at all, the smart vac routinereturns to step 904.

The scroll/vacuum routine is illustrated by a flowchart in FIG. 13. Withscreen image 81 displayed, the operator may use vacuum button 50 to setthe system to scroll through the screen icons or to perform other tasks.If display 334 shows screen image 81, then in step 921 the operator maypress vacuum button 50 once to, for example, open the axial vacuum line32 and lateral vacuum line 30 until vacuum button 50 is released. Whilevacuum button 50 is depressed, the forward button 46 and reverse button50 are disabled in step 925 and the current operational mode continuesin step 924. If at step 921 the control unit 300 recognizes that thevacuum button had been double-clicked, then the scroll routine engagesin step 922 and the status is displayed in steps 922, 923: “1. USEFORWARD OR REVERSE BUTTONS TO SCROLL, 2. USE VACUUM BUTTON TO SELECTMODE.” In step 927 one of the touchscreen mode control icons(positioning control icon 346, sampling control icon 348, clear probecontrol 350 icon) may be selected by using either the forward button 46(to scroll right to left one position each time forward button 46 ispressed) or the reverse button 48 (to scroll left to right one positioneach time reverse button 48 is pressed.) When the desired control iconis highlighted, the operator presses the vacuum button to enable theselected mode in steps 928 and 929. Otherwise, the operator may continueto scroll through the controls as described in step 927.

While preferred embodiments of the present invention have been shown anddescribed herein, it will be obvious to those skilled in the art thatsuch embodiments are provided by way of example only. Numerousvariations, changes, and substitutions will now occur to those skilledin the art without departing from the spirit and scope of the appendedclaims.

We claim:
 1. A biopsy system comprising: (a) a handpiece comprising aneedle and a cutter movable with respect to the handpiece; (b) a controlunit operably associated with the handpiece, wherein the control unit isoperable for selecting from two or more operational modes once thecontrol unit is powered on; and (c) a display operably associated withthe control unit, wherein the display is operable to toggle between anoptions screen and at least one operations screen, wherein the optionsscreen provides for access to the at least one operations screen,wherein the at least one operations screen provides for access to theoptions screen, wherein at least a portion of the at least oneoperations screen is configured to show a position of the cutter,wherein the options screen is configured to receive a plurality of userinputs, wherein at least one of the plurality of user inputs isconfigured to initiate an operation to replace at least one part of thebiopsy system with a new part.
 2. The biopsy system of claim 1 whereinat least a portion of the at least one operations screen represents areal time position of the cutter.
 3. The biopsy system of claim 1wherein the control unit is operable for selecting from at least threeoperational modes.
 4. The biopsy system of claim 1 wherein the controlunit is operable for selecting a positioning mode.
 5. The biopsy systemof claim 4 wherein the positioning mode is operable for positioning thecutter.
 6. The biopsy system of claim 5 wherein the positioning mode isoperable for positioning the cutter without rotating the cutter.
 7. Thebiopsy system of claim 1 wherein the at least one operations screencomprises a first region and a second region, wherein the at least oneoperations screen comprises at least one textual message region and atleast one region displaying a non-textual image.
 8. The biopsy system ofclaim 1 wherein the control unit is operable for providing a pulsedvacuum.
 9. The biopsy system of claim 1, wherein the handpiece comprisesa probe and a holster.
 10. The biopsy system of claim 9, wherein theplurality of user inputs of the options screen includes a new probeoption, wherein the new probe option is operable to initiate anoperation to replace the probe of the handpiece with a new probe. 11.The biopsy system of 9, wherein the plurality of user inputs of theoptions screen includes a new holster option, wherein the new holsteroption is operable to initiate an operation to replace the holster ofthe handpiece with a new holster.